Label: POVIDINE IODINE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient                                  Purpose

    Povidone Iodine 7.5% v/v                        Antiseptic                          

  • Inactive Ingredients

    Inactive Ingredient: Citric Acid, Glycerin, Sodium Citrate, Tween 80, Disodium Phosphate, Water

  • Purpose

    Purpose of povidone iodine scrub

    First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
    For preparation of the skin prior to surgery.
    Helps reduce bacteria that can potentially cause skin infections.

  • Warnings:

    • FOR EXTERNAL USE ONLY
  • Do not use:


    • As a first aid antiseptic for more than 1 week.
    • In the eyes.
    • Over large areas of the body.
  • Ask a doctor before use if you have:


    • Deep puncture wounds
    • Animal bites
    • Serious burns
  • Stop Use:


    • If irritation and redness develop
    • If condition persists for more than 72 hours, consult a physician.
  • Keep Out Of Reach Of Children

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.

  • Directions:


    As a first aid antiseptic

    • clean affected area
    • apply 1 to 3 times daily
    • may be covered with a sterile bandage, if bandaged let dry.

    For preoperative patient skin preparation
    • clean area
    • apply to operative site prior to surgery using the applicator


  • INDICATIONS & USAGE

    For use as an

    • first aid antiseptic
    • pre-operative skin preperation
  • Principal Display Panel

    povidone_iodine_scrub

    povidone_iodine_scrub

  • INGREDIENTS AND APPEARANCE
    POVIDINE IODINE 
    povidine iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-110-1648 in 1 CASE
    159 mL in 1 BOTTLE
    2NDC:67777-110-1148 in 1 CASE
    2118 mL in 1 BOTTLE
    3NDC:67777-110-1224 in 1 CASE
    3237 mL in 1 BOTTLE
    4NDC:67777-110-1324 in 1 CASE
    4474 mL in 1 BOTTLE
    5NDC:67777-110-1412 in 1 CASE
    5946 mL in 1 BOTTLE
    6NDC:67777-110-154 in 1 CASE
    63784 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/03/2002
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Degasa, S.A. de C.V.812771980manufacture(67777-110)
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